US8519004B2ExpiredUtilityA1

Dosing regimes for trans-clomiphene

75
Individually held — no corporate assignee on recordPriority: Mar 22, 2005Filed: Aug 20, 2012Granted: Aug 27, 2013
Est. expiryMar 22, 2025(expired)· nominal 20-yr term from priority
Inventors:Joseph S. Podolski
A61P 5/26A61P 5/32A61P 5/24A61P 5/28A61P 37/04A61P 3/06A61P 5/06A61P 35/00A61P 19/10A61P 15/00A61P 19/00A61P 21/06A61P 15/08A61P 15/10A61P 19/08A61P 21/00A61P 13/08A61K 31/138A61K 31/137
75
PatentIndex Score
2
Cited by
4
References
10
Claims

Abstract

The present invention relates to the use of compositions comprising trans-clomiphene for treating men with hypogonadism. The invention is also directed to methods for treating males with hypogonadism and disorders related thereto, including reduction of muscle mass. limitation of body performance capacity, reduction of bone density, reduction of libido, reduction of potency, reduction of benign prostatic hyperplasia and infertility.

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. A method for treating secondary hypogonadism or a disorder related thereto in a human male in need of such treatment comprising daily administration of a composition consisting essentially of trans-clomiphene or a salt thereof to achieve a pharmacologically effective blood concentration of testosterone and thereafter a 3 to 30 day interval between at least two consecutive administrations. 
     
     
       2. The method of  claim 1 , wherein the dose is 5 to 100 mg trans-clomiphene. 
     
     
       3. The method of  claim 2 , wherein the dose is 12.5 to 50 mg trans-clomiphene. 
     
     
       4. The method of  claim 3 , wherein the dose is 12.5, 25 or 50 mg trans-clomiphene. 
     
     
       5. The method of  claim 1  wherein the interval is 7 days. 
     
     
       6. The method of  claim 1  wherein the interval is 14 days. 
     
     
       7. The method of  claim 1  wherein the interval is 30 days. 
     
     
       8. The method of  claim 1  wherein the disorder related to secondary hypogonadism is selected from the group consisting of reduction of muscle mass, limitation of body performance capacity, reduction of bone density, reduction of libido, reduction of potency, benign prostatic hyperplasia, oligospermia or azoospermia, fatigue, depression and infertility. 
     
     
       9. The method of  claim 1  wherein the male is a fertile male and wherein fertility is maintained in the male. 
     
     
       10. The method of  claim 1  wherein the salt of trans-clomiphene is the citrate salt.

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